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Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06393452
Recruitment Status : Not yet recruiting
First Posted : May 1, 2024
Last Update Posted : May 20, 2024
Sponsor:
Information provided by (Responsible Party):
Pelage Pharmaceuticals, Inc.

Study Description
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Brief Summary:
The study is designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK following 28 days of administration.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: PP405 0.05% Topical Gel Drug: PP405 Topical Vehicle Gel Phase 2

Detailed Description:
Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia
Estimated Study Start Date : June 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: PP405 0.05% Topical Gel
0.05% Topical Gel applied once daily
 Drug: PP405 0.05% Topical Gel
PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)
Placebo Comparator: PP405 Topical Vehicle Gel
Placebo Topical Gel applied once daily
 Drug: PP405 Topical Vehicle Gel
PP405 Vehicle = placebo


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of subjects with treatment-related adverse events [ Time Frame: Baseline to Day 28 ]
    Collection of adverse events, treatment emergent adverse events and serious adverse events.

  2. Change in local dermal tolerability as assessed by subject and investigator [ Time Frame: Baseline to Day 28 ]
    Collection of local skin reactions using a 4 point scale (0-none, 1-mild, 2-moderate, 3-severe)


Secondary Outcome Measures :
  1. Pharmacokinetics of PP405 [ Time Frame: Baseline to Day 28 ]
    To assess the concentration of PP405 in plasma


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female subjects aged 18 to 55 years.
  2. Able and willing to provide written informed consent.
  3. Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V. Females must have a Savin classification score of I-2, I-3 or I-4.
  4. Agree to comply with protocol procedures

Exclusion Criteria:

  1. Concomitant diagnosis of non-AGA forms of alopecia.
  2. Use of other hair loss treatments within periods specified in protocol.
  3. Use of excluded medications as specified in protocol.
  4. Diagnosis of other medical conditions as specified in protocol.
  5. Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06393452


Contacts
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Contact: Lisa Sherman 213-218-3830 clinicaltrials@pelagepharma.com

Sponsors and Collaborators
Pelage Pharmaceuticals, Inc.
Investigators
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Study Chair: Christina Weng Pelage Pharmaceuticals
More Information
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Responsible Party: Pelage Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT06393452    
Other Study ID Numbers: PP405-2001
First Posted: May 1, 2024    Key Record Dates
Last Update Posted: May 20, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical